Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage

• Status: Withdrawn
• Trial end date: 2027-01-18
• Target enrollment: 0
• Participant gender: All

Summary

Brain bleed in premature infants damages the brain and survivors suffer from cerebral palsy (weakness in the extremities), cognitive deficits, and neurobehavioral disorders. In this clinical trial, investigators will test whether thyroxine (hormone from thyroid gland) treatment in premature infants with moderate-to-large brain bleeds show recovery in the brain structure on MRI evaluation at the time of discharge (44+/-1 weeks) and neurodevelopmental improvement at 2 years of age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine
• Collaborators: Arkansas Children's Hospital Research Institute; Brigham and Women's Hospital; Children's Minnesota Hospital; Morgan Stanley Children's Hospital; St. Louis University; University of Minnesota; University of North Carolina, Chapel Hill; University of Pittsburgh; Wake Forest University Health Sciences; Westchester Medical Center

Criteria

Inclusion Criteria

• NICU inpatients born between 23-0/7 and 27-6/7 weeks of gestation

• Postnatal age 2-5days (≥2 d ≤ 5 d)

• Unilateral or bilateral Grade 3 or 4 IVH

• Parental consent

Exclusion criteria:

• Major malformations, including surgical, cardiac, cerebral, chromosomal, or genetic syndromes, identifiable at or before birth;

• Congenital bacterial infection proven by culture at birth or viral syndrome known prior to delivery (e.g. chicken pox, rubella, etc.)